Phase III Study of Hyperfractionated Radiation Therapy With or Without Simultaneaous Application of CIS-Platinum in Patients With Moderately Advanced to Advanced Cancers of the Head and Neck
OBJECTIVES: I. Assess the time to treatment failure (local and regional) in patients with
moderately advanced and advanced squamous cell carcinoma of the head and neck (no distant
metastases) when treated with hyperfractionated radiotherapy with vs. without 2 courses of
simultaneously administered cisplatin. II. Assess the time to distant metastatic relapse,
overall survival, and toxicity in patients receiving these treatments. III. Evaluate whether
the potential tumor-doubling time is an indicator for risk of treatment failure in patients
receiving these treatments.
OUTLINE: Randomized study. Arm I: Radiotherapy plus Single-Agent Chemotherapy followed, as
indicated, by Surgery. Hyperfractionated external-beam tumor irradiation using photon
energies of 4-6 MV or electrons of 6-12 MV (interstitial brachytherapy boost to lesions of
the oral cavity allowed); plus Cisplatin, CDDP, NSC-119875; followed, in patients with
persistent disease (at the discretion of the surgeon), by resection of primary tumor or
involved nodes. Arm II: Hyperfractionated radiotherapy followed by Surgery. Tumor
irradiation as in Arm I; followed by resection as in Arm I.
PROJECTED ACCRUAL: At least 400 patients will be accrued over 5 years. Interim analyses to
allow for early stopping will be carried out after entry of 50 and 100 patients.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
Pia Huguenin, MD